MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR DRAW ROD FOR RESCUE SCREWDRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48770905B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of an aviator draw rod for rescue screwdriver broke intra-operatively during screw removal.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
A visual inspection was performed and the returned draw rod was confirmed to have a fractured tip.Device history records were reviewed for this lot, and no relevant manufacturing issues were identified.Device age approximately 7.5 years.A review of complaint history associated with the subject catalog number was performed, and no adverse trends were observed.The root cause of the reported event is normal wear and tear due to device age (as stated in device surgical technique, "consistent use of the instrument throughout its lifetime may cause fatigue".Additionally, the tip fracture occurred during removal of a plate from a fused area of the patient's spine, which may have required above average torsional force.
Event or Problem Description
It was reported that the tip of an aviator draw rod for rescue screwdriver broke intra-operatively during screw removal.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.

• Brand Name: AVIATOR DRAW ROD FOR RESCUE SCREWDRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 14090849
• Report Number: 0009617544-2022-00045
• Device Sequence Number: 5958617
• Product Code: LXH
• UDI-Device Identifier: 07613327276886
• UDI-Public: 07613327276886
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48770905B
• Device Catalogue Number: 48770905B
• Device Lot Number: 140656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown